Loperamid-BP

Loperamidum

Each tablet contains loperamide hydrochloride 2 mg. Excipient with known effect: lactose monohydrate.

Indication: Symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years of age.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Children under 12 years of age. - in patients with acute dysentery, characterised by bloody stools and high fever; - in patients with acute ulcerative colitis; - in patients with bacterial enterocolitis caused by invasive organisms, including Salmonella, Shigella and Campylobacter; - in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics. - Loperamid-BP must not be given where inhibition of peristalsis is to be avoided due to the possible risk of significant complications such as ileus, megacolon and toxic megacolon. Loperamid-BP treatment must be discontinued promptly if constipation, abdominal distension or symptoms of ileus occur.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Treatment of diarrhoea with loperamide is symptomatic only. Where the aetiology of the underlying condition is known, specific and appropriate treatment should be given wherever possible. In patients with diarrhoea, particularly children, fluid and electrolyte depletion may develop. In these cases, the most important measure is appropriate fluid and electrolyte replacement therapy. During treatment, patients must follow an adequate diet and an optimal fluid intake regimen. Loperamide treatment does not reduce the need for rehydration and restoration of electrolyte balance. Patients with symptoms of dehydration must exercise caution (dry mouth, thirst, reduced urine output, dizziness, reduced skin elasticity), particularly in […]